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NCT Number: NCT06398353

Investigating the Impact of Acupuncture on the Quality of Life of Primitive Headaches Patients

Primary headache is one of the most common neurological diseases in modern society, which seriously affects the patient's quality of life. Although the use of painkillers can alleviate primary headache symptoms, it may also cause drug dependence. Therefore, alternative therapies that do not rely on drugs have attracted increasing attention in recent years. Among them, acupuncture has been partially recognized by the public as an effective treatment for primary headaches. However, there is currently no scientific evidence that acupuncture is effective for primary headaches. The purpose of this project is to verify the effect of acupuncture in treating primary headaches. This study has three sub-projects:

Subproject 2 explores the impact of acupuncture on headache severity and quality of life in patients with primary headaches. We evaluate the quality of life before and after acupuncture treatment through professional questionnaires, including the Numerical rating scale (NRS), headache diary, depression, anxiety and stress scale (DASS-21), health quality of life measurement questionnaire, Migraine Disability Assessment Scale and SF-36 Taiwan version. Finally, these data will be combined with the pulseway analysis from the results of sub-project 1 to provide a comprehensive way to evaluate the treatment effect.

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Key information

Conditions

Headache Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, Select A State, 333323, Taiwan

Location status: Recruiting

Location contact

Chien-Chung Yang

CONTACT

[email protected]

03-3196200 ext. 2610

Chien-Chung Yang

PRINCIPAL_INVESTIGATOR

Chumgyili Li

CONTACT

[email protected]

03-2118800 ext. 5593

About this study

In this study, 120 subjects who already suffered from headache symptoms (such as dizziness, heavy head, lightheadedness, head fullness, migraine) were treated with acupuncture at acupuncture points, and the pulse diagnosis instrument was used to capture the subjects' symptoms during acupuncture. The pulse waves before and after are collected, compared and analyzed to complete this test.

After the subjects are accepted, they will go to the Acupuncture and Traumatology Department of the Department of Traditional Chinese Medicine of Chang Gung Memorial Hospital (Taoyuan Branch) at an agreed time for health education and filling out questionnaires. After filling out the questionnaire, participants can reserve a time for the test.

One person is tested each time, and each test lasts 70-80 minutes. Pulse waves are collected for 20 minutes before and after the test. The acupuncture treatment plan for each subject in this study was based on traditional Chinese medicine theory and published literature. The acupuncture points selected were bilateral Cuanzhu, Taiyang, Tianzhu, Fengchi, Baihui, Hegu, Neiting, Zusanli, Waiguan, and Zulin. Qi, Houxi, Shenmai, Taichong. The doctor will select the above 4-6 acupoints according to the disease. It is divided into an acupuncture group and a sham acupuncture group. Before the experiment, first fill out the questionnaire. This trial is divided into an acupuncture group and a sham acupuncture group. A crossover design is adopted. 50% of the subjects will be assigned to the acupuncture group first. Then they will be connected to the sham acupuncture group, and the other 50% of the subjects will be assigned to the sham acupuncture group first and then the acupuncture group. Each group will last for two weeks, and acupuncture will be performed twice a week at the set acupuncture points. The first group of acupuncture will end. , will be interrupted for two weeks, and then another set of tests will be conducted, and then the patient will go to Chang Gung Memorial Hospital Taoyuan Branch for the final scale and quality of life questionnaire. The total trial period was eight weeks.

While undergoing the test, try to avoid taking Chinese and Western medicines and alcoholic beverages to avoid interfering with the study. (If participants usually take antihypertensive drugs and heart drugs, participants can continue to take them.) After the test, participants should drink more warm water and get enough rest. Do not take a shower or touch or drink cold things.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to sign a written subject consent form
  • Male or female over 18 years old
  • Those who have headaches (for example: dizziness, heavy head, dizziness, head fullness, migraine), those who have headaches more than twice a week, and whose NRS score is ˃ 4.
  • Headache definition: Headache symptoms are classified according to the ICHD-3 headache classification of the International Headache Organization, and are mainly primary headaches.

Dr. Chang ,Y.-J. and Dr. Yang ,C.-C. help to exclude headache patients with the following exclusion conditions to reduce the risk to subjects.

Exclusin Criteria

  • Pregnant women
  • Various acute and chronic infectious diseases, various skin ulcers, sores, burns, etc.
  • The patient has injuries to the radial artery or wrist, or has steel nails, plates, or fractures.
  • Various types of headaches related to anatomical structural lesions
  • Headaches associated with taking or withdrawing from substances (drugs, food, or other chemicals)
  • Headaches related to non-head infections and metabolic diseases
  • People with painful cranial neuropathy, other facial pain and other headaches
  • People with secondary headaches according to ICHD-3 beta
  • Other patients who have been evaluated by physicians as not suitable for inclusion in the evaluation.

Treatment and study plan

Real acupuncture

Other

Real acupuncture twice a week for two weeks

Sham Acupuncture

Other

Sham acupuncture twice a week for two weeks

Primary outcomes

  1. Numerical rating scale

    Time frame: 2 minutes

    Numerical rating scale (NRS) is the most commonly used pain intensity assessment tool at home and abroad. A straight line that is actually 10 centimeters, marked with "0" on the far left and "10" on the far right. Explain to the patient that "0" means no pain and "10" means very painful. The pain level increases from left to right, so that the patient can Draw vertically with a pen a few centimeters where the pain feels and record it in centimeters. You can also simply explain to the patient orally the meaning represented by "0" to "10" and let the patient rate it (verbal rating).

  2. The Depression, Anxiety and Stress Scale (DASS-21),

    Time frame: 7minutes

    The Depression, Anxiety and Stress Scale (DASS-21), also known as the "Self-Rating Emotion Scale" is a self-report scale that effectively assesses depression, anxiety and stress levels of the general population; it has 21 questions in total and takes time About 5 minutes. Although this scale cannot replace professional clinical diagnosis, nor can it be used as a basis for diagnosis alone, it has a significant screening effect on minor mental health problems.

  3. Europe health-related quality of life questionnaire 5 dimensions (EQ-5D)

    Time frame: 7minutes

    Europe health-related quality of life questionnaire 5 dimensions (EQ-5D) is a preference-based health life quality measurement tool. It includes 5 self-classifier questions and 0 - Two parts including a 100-point self-assessment scale for current health status.

  4. The headache diary

    Time frame: 20minutes

    The headache diary is to record your own headache diary every day, which can make it easier to communicate with the doctor about your pain condition and help the doctor treat primary headaches.

  5. Migraine Disability Assessment Questionnaire (MIDAs)

    Time frame: 7minutes

    Migraine Disability Assessment Questionnaire (MIDAs) In 1999, Stewart and Lipton proposed the Migraine Disability Assessment Questionnaire (MIDAs). This scale mainly consists of five questions, asking the patient to recall the impact of migraine on schoolwork or work, household affairs, and family, social or leisure activities during the past three months. This questionnaire is also used in Japan, Upper Turkey, Italy and other countries because it is simple and easy to use and has good reliability, validity and objectivity evaluation.

  6. The Taiwan Short Form 36 Health Scale (SF-36)

    Time frame: 20minutes

    The Taiwan Short Form 36 Health Scale (SF-36) is a widely used health-related quality of life questionnaire and is also used by people with different cultural backgrounds. Research results show that SF36 has been proven to have good reliability and validity regardless of the diagnosis, age, and gender of the test subjects, and it can also sensitively detect changes before and after treatment without falling. Therefore, this study uses SF36 as the outcome measurement tool for this study.

Study contacts

Contact information is provided by the study sponsor or research team.

Chien-Chung YANG

CONTACT

[email protected]

03-3196200 ext. 2610

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 3, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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